Consolidated body fluid testing device and method

ABSTRACT

A body fluid testing device includes a body member and a tissue penetrator carried by the body member. A test strip holder is carried by the body member, and a test strip is carried by the test strip holder. The test strip is capable of receiving a body fluid thereon and processing the body fluid into a form suitable for yielding test results relating to the content of the body fluid.

I. CLAIM OF PRIORITY

[0001] The instant application claims priority to Kloepfer, Kloepfer andRoach, U.S. Provisional Patent Application No. 60/340,442 filed Dec. 7,2001.

II. TECHNICAL FIELD OF THE INVENTION

[0002] The present invention relates to methods and devices for testinganalysis fluids, and more particularly to a consolidated testingapparatus for use in performing analyses of one or more components of afluid. Significant contemplated applications of the invention are in thebiological sciences, especially diagnostic medicine. In this field,analysis fluids would primarily be bodily fluids, notably whole blood.

III. BACKGROUND OF THE INVENTION

[0003] A. Overview of Disease Conditions Warranting a Need for thePresent Invention.

[0004] Diabetes has been referred to as the “undiagnosed epidemic of thethird millennium”. Some experts predict the number of diabeticsworld-wide to triple over the next 15 years to about 320 million.Self-monitoring of blood glucose (SMBG) is considered the quintessentialprerequisite for diabetes management and treatment. As will be explainedin more detail, most current SMBG systems, whether designed for patientor professional use, still have significant limitations.

[0005] Diabetes has reached alarming proportions in the western worldand is growing at epidemic rates in countries other than the westernworld. Strategies for diagnosis and care are well developed (thoughstill sub-optimal) in the western world, but marginal in developingcountries.

[0006] The three major types of diabetes are type 1 (formerlyinsulin-dependent diabetes mellitus, IDDM, juvenile-onset), type 2(formerly non-insulin-dependent diabetes mellitus, NIDDM, adult-onset),and gestational diabetes. About 130,000 children in the US have type 1diabetes. Treatment for type 1 consists of insulin injections, diet andexercise.

[0007] In type 2 diabetes, treatment may include insulin, but preferablyoral glucose lowering agents, diet, weight reduction and exercise.Approximately ninety percent (90%) of diabetics are type 2.

[0008] Powerful drivers for rising prevalence of diabetes and impairedglucose tolerance (IGT) in the US are growing minority populations,along with the graying, and the fattening of America. The yearly deathtoll from diabetes is one half million. Diabetics are predisposed toheart disease, peripheral vascular disease, stroke, retinopathy, kidneydisease and neuropathy. The latter is associated with amputations,silent myocardial infarction and sudden death, and it accounts for over300,000 hospitalizations each year. The number of annual hospital daysis 6 million and emergency room visits close to 600,000.

[0009] Direct costs in 1992 were estimated at $39.1 billion forinstitutional and $6.2 billion for outpatient care. Today's totaldiabetes-related toll to the US economy (direct and indirect costscombined) is estimated to approach $150 billion.

[0010] As a true cure for diabetes remains elusive, tight glucosecontrol will continue to be the sine-qua-non of diabetes combatstrategies. The benefits of tight glucose control in curbingdiabetes-related complications are now authoritatively documented. Thisevidence also suggests that a large portion of type 2 diabetics maybenefit from tight glucose control and insulin. As worldwide knowledgeabout diabetes will be nurtured by the information age andmedia-assisted education, masses of undiagnosed diabetics who wouldbenefit from tight glucose control will eventually be brought into thesystem. Since testing technology will also further mature, thesemegatrends will co-functionally establish an enormous market for SMBG inthe future.

[0011] B. Discussion of Prior Art Products and Techniques

[0012] The mainstay of treatment for type 1 and many type 2 diabetics isSMBG in conceit with responding self-administration of insulin toharmonize glucose levels. Current SMBG systems are typically comprisedof a test strip-type, dry chemistry device. The test strip is insertableinto a hand-held meter that contains a display that gives the user aread-out of results. Alternately, results can be obtained by comparingreaction colors to printed color charts. The combined 1998 world marketfor teststrips, meters and auxiliary products (lancets, stickingdevices, swabs, etc.) was $3 billion and is now in excess of $4 billion,with $2 billion in the US alone. Long term growth projections for themarket are 12-15% per annum.

[0013] Approximately two thirds (⅔) of the market is in teststrips.Examples of known test strip and meter systems are those sold by BeyerDiagnostics; Cascade Medical; LXN Corporation; LifeScan; MediSense;ReliOn; Roche Diagnostics; Terumo Corporation and TheraSense.

[0014] From a provider perspective, the main shortfall is that currentsystems are generally limited to the measurement of glucose. This is indrastic discord with the concept of diabetes as a multi-factorialmetabolic syndrome. From a user point of view, there are stilllimitations in those features that consumers and users believe to beimportant, such as (1) minimal invasiveness; (2) speed of analysis and(3) ease of performance and minimal complexity (inconvenience) fromprimary and auxiliary product mixes.

[0015] The vast majority of current SMBG systems utilize more or less“invasive” technology as they require that finger tips be lanced tocause bleeding, which is the source of blood used in the test. Mostcurrent devices require the finger to be lanced to obtain blood samplesin a range between 2 and 30 ml. Non-invasive and minimally invasivetechnologies (such as the one of the instant invention) have been underactive development for years, but made it to market only on a verylimited scale due to technical difficulties.

[0016] 1. Invasive Systems. Several dry-chemistry technologies exist fortesting of whole blood specimens. In most devices liquid reagents areapplied onto solid Support substrates by some impregnation or coatingmethod. After solvent evaporation, the dry and therefore stable reagentis contained within a reactive zone or signal member (test field). Asthe blood sample makes contact with the reagents on a test strip, achemical reaction is initiated with the analyte to be measured.

[0017] Both photometric and electro-sensimetric detection principles arein use for measuring compounds of interest in the reagent-reactedanalyte on the test strip. Most systems employ reflectance photometry.In these meters, light of a wavelength absorbed by the colored reactionproduct is shined onto the surface of the test field and the reflectedportion of the light is monitored. In contrast to conventionalphotometry where absorbance is measured from reduced light transmittancein the direction of the incident beam, reflectance is measured atlocations angled away from incident light. As light of varyingwavelengths is reflected in different directions, an informed choicemust be made as to which incident and reflective angles to select forobtaining a signal that is most sensitively and most specificallyrelated to concentration.

[0018] Preferably, the photocurrent detector (photodiode) of themetering device is positioned at a location where unspecific scatteringis minimal, and specific reflectance is maximized. However, since thetwo can usually not be completely spatially separated, pure signals areby definition unobtainable.

[0019] An advantage of photometric systems is that they measure color.Potentially, this enables both visual and instrumented signalrecognition. Visual interpretation can serve as a confidence check forquantitative results provided by the meter. Importantly, in marketswhere meters are not readily available, glucose concentration can stillbe determined semi-quantitatively by a visual comparison of reactioncolors on the test strip to standardized color charts.

[0020] Unfortunately, the important feature of visual backup is realizedonly in a minority of present systems. This limitation resides in themethod by which cellular component of blood is separated from plasma. Inolder products plasma was separated by soak through methods into coatedbibulous materials or reagent films. Cells were then manually removedfrom the site of blood application by either washing or wiping themaway, potentially giving rise to significant operator-induced errors.

[0021] Several newer methods permit separation by means other thanwashing or wiping. The most frequently used methods are separation byporous glass fiber fleeces or membranes. In these matrices pore sizesare chosen so that cellular component is held back within the matrix,whereas plasma diffuses through the separating and into the detectionlayer.

[0022] 2. Non-Invasive (NI) and Semi-Invasive Technology. The dream goalfor the SMBG market of a completely non-invasive glucose monitoringtechnology, although pursued for over a decade, has so far provenelusive, despite perennial promises from companies in the industry.These failures have led to predictions that completely non-invasiveoptical technology (infrared or other) may not make it to market in anysignificant way, for both cost and technical reasons. It is also arguedthat this lack of success was predictable from early theoreticalconsiderations of signal engineering. These considerations include thenumerous and variable challenges of isolating a meaningful signalagainst a background of overpowering non-specific noise, such as noisefrom water. An authoritative recent review of NI glucose testingtechnology concludes that: “ . . . none of the NI experiments reviewedprovides proof that the signal is related to actual blood glucoseconcentration. Clark error grid presentation shows performance that isnot acceptable for home glucose meters.”

[0023] A promising alternative to non-invasive is “semi-invasive” orminimally invasive testing using interstitial fluid (IF). The onlyproduct currently marketed that employs this technology is Glucowatch™from Cygnus, Inc. It uses electrically stimulated (reverseiontophoresis) glucose extraction from IF into a sensor-equipped samplepad. The product was recently approved by the FDA but only forsupplementary (trend) testing. Reported problems with IF sampling arevariations in skin thickness and permeability, changes in blood/IFequilibration, sweating, signal instability and skin irritation.Furthermore, the watch must be recalibrated every 12 hrs. which is doneby invasive finger stick measurements.

[0024] In the future the SMBG market will increasingly be driven byconsumer demand, managed care, and cost pressures from third partyreimbursement companies. In this environment a market conversion fromestablished and affordable invasive whole blood technology to unprovenand costly non-invasive systems appears unlikely. However, it isexpected that the market will migrate to invasive systems which minimizeinvasiveness and its associated pain. As such, the Applicant's minimallyinvasive and relatively less painful technology is believed byApplicants to better achieve the goals sought by the industry, and bewell placed in the direction in which the market is heading.

[0025] C. The Present Invention Strives to Improve over the Known PriorArt.

[0026] One development goal is to remove, or at least decrease the painassociated with finger sticks and reduce the complexity of testperformance by reducing the number of separate components required toperform a blood test.

[0027] An inventive feature of the Applicant's invention is theconsolidation of the test procedure components with the exception of themeter, into one single disposable test strip device. The product“clutter” of the prior art non-meter components including test strips,meters, lancets, lancet shooting devices, alcohol bottles or sealedswabs, multiple vials and bags requires the user to assemble and spreadout a multitude of separate components on a flat surface such as a tableor counter top, before testing can even begin. It is a perceived burdenby users, and a deterrent for many diabetics to perform SMBG at all. TheApplicants' innovative concept of sweeping consolidation of a multitudeof components into one single disposable of lancing site preparation,painless lancing (tiny sample, e.g. forearm), dosing andnon-instrumented monitoring should reduce perceived inconvenience to theabsolute minimum, making testing easier and widely accessible to thepublic. In instrument monitored versions, the monitor (meter) willcomprise a second component.

[0028] The technology has four (4) contributive components: (1)unitization of lancing site preparation, lancing, dosing and testing;(2) direct (filter-less) absorption of blood plasma into polymer-basedreagent films; (3) removal of cellular component by capillary force; and(4) visual recognition of designated glucose cut-points by the novelthreshold assay (redox titration on a test strip) principle (innon-instrumented versions). In this mode of operation, only a singlepolymeric film with a thickness in the micrometer range (<50 m dry film)is required for instant accommodation of both plasma acquisition andchemical analysis. Feasibility in theory and experiment for thecandidate technological principles has been demonstrated by Applicants.

[0029] Elements of the consolidated testing device of the presentinvention are: (1) incorporation of a lancet into a test stripcontaining device at a side opposite to blood entry capillary with thatside becoming the (currently separated) lancet/plastic support unit; (2)incorporation of an antiseptic cleaning swab into the lancet cap and (3)incorporation of a pressure cup into the lancet cap lid for focusedacquisition of miniature blood specimens by enhancing blood flow fromtissue site that, under normal conditions do not yield sufficient bloodfor testing purposes.

[0030] These steps eliminate product clutter by obviating separatevials, swabs, lancets, and lancing gun. Additionally, these steps helpto synchronize purchasing of disposables which reduces frequent trips toa pharmacy. The consolidation of the testing components will also maketesting faster, and less dependent on finding a suitable environment,such as a washroom, test surface, and/or disposal bin. As such, theApplicants consolidated device should be safer and more user friendly.

[0031] A third developmental goal of the consolidated testing apparatusof the present invention is the ultra-miniaturization of the sample sizerequired to be taken from a patient in order to perform the test.Ultra-miniaturization of sample size is enabled by a proprietary thinfilm, capillary-augmented sample acquisition process which is describedin more detail in Kloepfer et al., U.S. patent application Ser. No.09/696,156, which was filed on Oct. 25, 2000, and contains a disclosurewhich is incorporated herein by reference.

IV. SUMMARY OF THE INVENTION

[0032] In accordance with the present invention, a body fluid testingdevice includes a body member and a tissue penetrator carried by thebody member. A test strip holder is carried by the body member, and atest strip is carried by the test strip holder. The test strip iscapable of receiving a body fluid thereon and processing the body fluidinto a form suitable for yielding test results relating to the contentof the body fluid.

[0033] In the preferred embodiment of the present invention, the devicealso includes a cleansing member with a pressure inducing member. Thecleansing member is carried by the body member for cleansing the tissuearea to be penetrated by the tissues penetrator. The cleansing memberincludes an aperture, and, along with the penetrator, is disposedadjacent to the first end of the body portion. The penetrator isextendable through the aperture of the cleansing member, as thepenetrator moves from its retracted position, to its axially extendedposition. Preferably, tissue penetrator includes an actuator forretaining the tissue penetrator in the retracted position releasing thetissue penetrator upon activation by the user, to move into the extendedposition. The tissue penetrator can include a depth adjustor forpermitting the user to adjust the axial distance traveled by the tissuepenetrator between its retracted and its extended position.

[0034] The pressure inducing member preferably comprises a cap memberdisposed adjacent to the first end of the body member. The cap member ishingedly coupled to the body member, and is movable between a closedposition, wherein the cleansing member and the penetrator are covered bythe cap member, in an open position. When the cap member is closed, itis disposed generally co-axially with the body member. The cap memberincludes a tissue engaging rim that defines an axially inwardlyextending cavity.

[0035] One feature of the present invention is testing consolidation,i.e. unification of the various components needed to test blood into asingle testing device. The Applicants believe that it is advantageous tokeep the testing meter as a separate component, because to incorporate atesting meter into the remainder of the components (lancet, lancet gun,test strip and cleansing swab) would make the device too expensive to bedisposable. Rather, the Applicants believe that cost-efficiencies andsanitary concerns are best addressed with a removable meter that isemployed with a disposable testing device that includes the lancet,lancet gun, test strip and cleansing swab.

[0036] The Applicants believe that the consolidated testing device ofthe present invention will greatly reduce apprehension, inconvenienceand fear and should receive a warm welcome from diabetics. A reductionin the fear factor is achieved by employing a retractable lancet, whichis not seen by the user, thus lessening the “needle fear” caused by thesight of a traditional exposed lancet.

[0037] In one embodiment, the testing device has a removable andreplaceable swab cap holding the cleaning fluid swab. Upon removal ofthe peel-off lid, the swab (cellulose or polypropylene sponge) protrudesoutward because of interior pressure from material elasticity. The usercleans the intended lancing site, removes the lancet cap and lances thesite by applying perpendicular pressure against the skin. He then recapsthe lancet unit and turns the device 180 degrees, draws the sample intothe reaction capillary, waits for removal of excess blood and monitorsthe result.

[0038] In another embodiment, the removable lancet cap has been replacedwith a living hinge snap cap. In this embodiment the cleaning swab isenclosed within the snap cap. The exterior side of the snap cap featuresa dome shaped pressure cup for sample enlargement (when necessary),activated by pressing the cup against the lanced site. This pressureagainst the lanced site helps to enhance the flow of blood from thelanced site, thus ensuring a sufficient supply of blood to meet thequantity needs of the test strip and meter.

[0039] Another aspect of the consolidated testing device feature of thepresent invention is that it reduces the number of separate items thatthe user must handle from about six items to a single item. Current SMBGsystems require at least half a dozen items to enable a user to performa blood test. In addition to the meter, these items include a teststrip, lancet, lancet shooting device, calibration strips, alcohol swab,bags, vials, and caps. These items must be removed from a common pouch,assembled and handled to perform a single, sterile test, and thenrepackaged. The proposed consolidated technology would require a personto handle only a single disposable, the test strip/lancet/swab/pressurecup unit (along with a meter), thereby reducing product clutter. Besidesgreatly facilitating ease and speed of performance, this unitizationconcept has the potential to streamline parts inventory control and savediabetics intermittent trips to the pharmacy every time they run out ofa particular item.

[0040] The consolidation concept is particularly suited for alternatesite testing (AST such as by withdrawing blood from the forearm, ratherthan a finger tip. AST is becoming increasingly popular because (1) painfrom finger sticks is eliminated, and (2) available lancing surfaces aresignificantly increased. The amount of blood obtainable from a forearmstick is one magnitude less than what can be acquired from a fingerstick. Because of this, many prior art blood test systems were unable toutilize AST, as insufficient amount of blood were obtained from theseAST sites to satisfy the requirements of either or both of the teststrip and meter.

[0041] Although Bayer and MediSense have introduced vacuum assisteddevices that are useful for obtaining greater blood flow quantities fromalternative sites, the Applicants have found that the application of avacuum is unnecessary. Surprisingly, the Applicants have found thatpressure applied around the lancing site will cause increased bloodflows. One feature of the present invention is that a pressure inducingcomponent such as a pressure cup is provided that increases blood flowat alternative stick sites, without the need for a vacuum assist

[0042] Through repeated experiments (at two different body sites) theApplicants have demonstrated that sample volumes can be increased 5-10times when a pressure cup is applied as opposed to unassisted bloodacquisition. In these studies we used one of the smallest lancetscurrently marketed, the Roche Softclix, at the lowest of its 11 depthsettings=0.5). With unassisted lancing, blood volumes obtained werebetween 0 and 200 nanoliter.

[0043] In some sticks no blood was obtained at all. However, even inmost of those “no-blood-obtained” cases, sufficient blood could beextracted when a cup was pressured against the sticking site. Such apressure cup can be incorporated into the consolidated test device.

[0044] Several advanced designs of consolidated teststrips enhancingfunctionality and ergonomics are part of the present invention.Advantages of the advanced designs are: (1) elimination of one part(separate swab cap), streamlining production; (2) continuouslyadjustable depth penetration of lancet owing to a co-molded, eccentriccam lancet cap stop wall; (3) capacity for repeat lancing in the eventof an insufficient sample volume; (4) provision of a pressure cup toenlarge sample volumes obtained from sticks <300 nL; (5) therepositioned “living hinge” swab cap serves as a protective cover forthe lancet, providing additional safety by preventing presence of usedand exposed lancets in temporary and mass disposal, and (6)substantially improved user handling and ergonomics.

[0045] The entire consolidated test strip can be manufactured from three(3) injection molded parts joined together by two (2) snap-inconnections, assembled with the punched foils that contain the testchemistry.

[0046] Additional objects, advantages and novel features of theinvention are set forth in the description that follows, and will becomeapparent to those skilled in the art upon their viewing the drawings inconnection with the following description.

V. BRIEF DESCRIPTION OF THE DRAWINGS

[0047]FIG. 1 is an exploded perspective view of the consolidated bloodtesting device of the present invention;

[0048]FIG. 2 is another exploded perspective view;

[0049]FIG. 3 is an assembled perspective view of the present invention;

[0050]FIG. 4 is another assembled perspective view of the presentinvention;

[0051]FIG. 5 is an exploded perspective view of a first alternateembodiment of the present invention;

[0052]FIG. 6 is another perspective view of the first alternateembodiment of the present invention;

[0053]FIG. 7a is a schematic flowchart illustrating the steps necessaryto perform a blood test using the prior art;

[0054]FIG. 7b is a flowchart illustrating the steps necessary to performa blood test using the testing device of the present invention;

[0055]FIG. 8 is a bottom view of the first alternate embodiment of thepresent invention;

[0056]FIG. 9 is a top view of the first alternate embodiment of thepresent invention;

[0057]FIG. 10 is a side view of the first alternate embodiment of thepresent invention;

[0058]FIG. 11 is a perspective view, illustrating the pressure cap ofthe present invention;

[0059]FIG. 12 is a perspective view, wherein the pressure cap in itsopen position, and the cleansing swab is exposed;

[0060]FIG. 13 is a perspective view, similar to FIG. 12, but with thecleansing swab removed to illustrate the cleansing swab receivingchamber;

[0061]FIG. 14 is a top view thereof showing the chemistry strip removed;

[0062]FIG. 15 is a bottom perspective view of a second alternateembodiment of the present invention;

[0063]FIG. 16 is a top perspective view of the perspective view of thesecond alternate embodiment of the present invention, with the dial capremoved;

[0064]FIG. 17 is a bottom perspective view thereof;

[0065]FIG. 18 is a top view of the present invention, similar to FIG. 17however with the dial member included and the lancet cap removed;

[0066]FIG. 19 is a top perspective view of the base member, includinglancet of the second alternate embodiment; and

[0067]FIG. 20 is a perspective view, second alternate embodiment withthe dial cap in place and the cleansing swab removed.

VI. DETAILED DESCRIPTION

[0068] The first embodiment of the testing device 10 of the presentinvention is shown in FIGS. 1-4 as including a body 12 that includes afirst end body portion 14 that is attachable to and joinable with asecond body portion 16 to form the assembled testing device 10, as shownin FIGS. 3 and 4. The testing device 10 is generally pen-shaped, andincludes a longitudinally extending axis A, which will be used as areference point to describe the various surfaces and directional extentof the components of the testing device 10. The first end body portion14 includes a radially outwardly facing cylindrical surface 20 having aknurled or otherwise roughened gripping surface 22 for enhancing theuser's ability to grip and control the device 10. The first end bodyportion 14 also includes an arbitrarily designated proximal end 24 and adistal end 26. A reduced diameter portion 28 is disposed adjacent thedistal end 26. The reduced diameter portion 28 is sized for interiorlyreceiving the proximal end of the second end body portion 16 within thegenerally hollow interior passageway 30 of the distal end 26. Thegenerally hollow interior passageway 30 is defined by a generallycylindrical interior surface 32.

[0069] A bundt cake pan-shaped cleansing member receiver (not shown) isdisposed within the interior of the proximal end 24 of the first endbody portion 14, and is sized and configured for receiving atoroidal-shaped absorbent cleansing member 36, that preferably comprisesan absorbent pad that absorbantly holds a disinfecting agent, such as arelatively non-volatile alcohol, or other disinfectant, such as thosecontaining anti-microbial and anti-germ agents such as Nonoxyl-9. Thecleansing member 36 has a radially extending, axially outwardly facingsurface 38, and a radially extending, axially inwardly facing surface40.

[0070] An axially extending central aperture 42 extends through thecleansing member 26 between the inwardly and outwardly facing surfaces38, 40, and is sized to be received by the axially extending hollowcentral finger (not shown) of the cleansing member receiver. As will bedescribed in more detail below, the central aperture 42 and hollowfinger of the cleansing member receiver are sized and positioned topermit lancet 50 to pass therethrough, so that when lancet 50 is in itsfully extended position, the penetrating tip 81 of the lancet 50 willextend axially outwardly beyond the axially extending outwardly facingsurface 38 of the cleansing member 36. Of course, when the lancet 50 isin its retracted position, the penetrating tip 81 is disposed axiallyinwardly of the axially outwardly facing surface 38 of the cleansingmember 36, so that a person using the cleansing member 36 to disinfectand clean a body tissue area prior to penetration does not stick himselfwith the lancet 50.

[0071] Cap member 54 is hingedly coupled to the first end body portion14 by a snap-type living hinge member 56. The cap member 54 is movablebetween an open position (as shown in the figures, )wherein thelongitudinal axis of the cap member 54 is generally parallel to thelongitudinal axis A of the testing device, and a closed position. In theclosed position, the cap member 54 rotates 180 degrees about the pivotformed by hinge member 56, and is disposed in a generally co-axialrelationship with the proximal end of the first end body portion 14.When in a closed position, end 60 of the cap member 54, that is shown asbeing a proximal end in FIG. 1, becomes the distal end 60 of the capmember 54, and the other end 62 of the cap member 54, that is shown inFIG. 1 (in the open position) as being the distal end, becomes theproximal end 52 of the cap member 54.

[0072] The distal end 60 of cap 54 is designed to mate with the proximalend 24 of the first body portion 14, when the snap-type living hinge 56moves the cap member 54 to its closed position. Although, ideally themating between the distal end 60 of the cap member 54 and the proximalend 24 is a sealing relationship of the type that prevents anydisinfecting agent within the cleansing member 36 from evaporating, itis possible that some sort of covering will need to be placed over theaxially outwardly facing surface 38 of the cleansing member 36 toprevent any volatile disinfectant absorbed within the cleansing member36 from evaporating during the time period between when the device 10 ismanufactured and when the device 10 is finally used by a patient.

[0073] As stated above, the living hinge members 56 are “snap-type”living hinge members that are designed to be spring-tensioned so thatthe cap 54 only finds a rest position when the cap 54 is either in itsopen position as shown in FIG. 1, or in its closed position wherein thecap 54 is disposed co-axially with the second body portion 14. Thissnap-type spring arrangement of the living hinge 56 facilitatesmanipulation of the device by the user, because the opening of the cap54 will cause it to snap into its fully open position, rather than toflop around within an arc of open positions.

[0074] The proximal end 62 of the cap member includes a pressure cup 64that is defined by a circumferential pressure inducing lip 66, and acup-shaped interior 68. As will be described in more detail below,placement of the circumferential pressure exerting lip 66 on a tissuearea that surrounds a tissue site that has been penetrated by the tissuepenetrator, along with the application of a moderate amount of axiallydirected force, has been surprisingly found by the Applicants to inducea flow of blood out of the penetrated site to enhance the volume ofblood that is obtained from the penetrated site. This feature has theadvantage of enabling the testing device to obtain a sufficient quantityof blood from testing sites, such as the forearm, that formerly wereunuseable by blood test strips because they normally did not bleedsufficiently to yield enough blood to enable the user to perform a bloodtest. In the prior art, this inability to obtain a sufficient quantityof blood required the user to obtain blood samples from sticks made onthe user's fingertips, as the finger tips yielded sufficient blood.

[0075] An axially movable tissue penetrator 72, that is movable betweenthe retracted position, and an extended position includes a needle-liketissue penetrating lancet 50, that is fixedly coupled to an axiallymovable mounting carriage 78. It will be noted that the mountingcarriage 78 and the lancet 50 are coupled to the first end of a portion16. However, when the device 10 is assembled, as shown in FIGS. 3 and 4,the carriage 78 and lancet 50 are interiorly received within the hollowinterior 30 of the first end portion 14, so that the penetrating tip 81of the lancet 50 is disposed adjacent to the proximal end 24 of thefirst end body portion 14.

[0076] As alluded to above, the lancet 50 normally resides in itsretracted position where the penetrating tip 81 is disposed axiallyinwardly of the axially outer facing surface 38 of the cleansing member36, so that when the user employs the cleansing member 36 to cleans hisfinger, he does not stick himself with the tip 81 of the lancet 50. Thelancet 50 is also movable into an extended position, wherein it is movedaxially outwardly, under the force of a biasing member, such as spring82 so that the penetrating tip 81 extends axially outwardly beyond theaxially outer facing surface 38 of the cleansing member 36, to prick thetissue site to cause bleeding therefrom.

[0077] One end 76 of the lancet 50 is coupled to a mounting collar onthe carriage 78, that couples the lancet 50 to the carriage 78. Lancet50 can be fixedly coupled to the movable carriage 78, and the carriage78 can be designed to move axially, to cause the axial movement of thelancet 50. Alternatively, the carriage 78 can be fixedly positioned, andthe lancet 50 be designed to be axially moveable relative to thecarriage 78.

[0078] Spring 82 is provided for biasing the lancet 50 to move in anaxially outward direction, to engage tissue. A trigger member 84 isprovided for maintaining the lancet 50 in its retracted position, untilthe user actuates the trigger 84, that permits the spring 82 to move thelancet 50 to move axially outwardly, to thereby prick a tissue surface.Although a single spring 82 is shown in the figures for biasing thelancet 50 to move axially outwardly, a dual-acting spring arrangementcan be designed that enables the lancet 50, upon actuation of trigger 84to move axially outwardly to engage a tissue surface, with a secondspring being provided to move the lancet 50 axially inwardly to retractit after the tissue poke is made.

[0079] A depth gauge 86, including a camming surface for facilitatingaxial movement (not shown) is provided for enabling the user to adjustthe extent of axial movement of the lancet 50, that permits the user toadjust the depth to which the penetrating tip 81 of the lancet 50penetrates the tissue surface of the user. As will be appreciated, someusers would prefer that the lancet 50 penetrate more deeply, to ensure abetter blood flow and supply, whereas others would prefer that thelancet 50 make a more shallow penetration of the tissue, that wouldlikely be less painful. The depth gauge 86 includes pointer 88 that isreconcilable with a gauging surface (surface 28) for maintaining one ormore numerical indicators, such as numerical indicator 89 (FIG. 4) thatprovides an indication to the user of the relative depth to which thelancet 50 will penetrate. A gripping surface 92 is provided forpermitting the user to rotate the cylindrical gauging wheel thatcontains gripping surface 92 on pointer 88 (or alternately, to rotatefirst end body portion 14) to permit the user to vary the insertiondepth of the lancet 50.

[0080] The second end body portion 16 also includes a test stripcomponent 94 that is disposed generally at the distal end 96 of thesecond end body portion.

[0081] The test strip component 94 is disposed at the distal end of thesecond end body portion 16, and includes four primary components, a teststrip 98, a test strip holder 100, a test strip retainer 102, and aliving hinge mechanism 104 for hingedly coupling the test strip holder100 to the retainer 102. Test strip retainer 102 is movable between anopen position (as shown in the figures) and a closed position (see,e.g., FIGS. 8-10). When the test strip retainer 102 is in its closedposition, the test strip 98 is sandwiched between the test stripretainer 102 and the test strip holder 100 to maintain the test strip 98in its appropriate position on the device 10.

[0082] The test strip 98 is preferably a capillary containing test stripof the type described in Kloepfer, Kloepfer and Roach patent applicationSer. No. 09/696,156, that is also assigned to the Assignee of theinstant invention. Although the disclosure relating to the test strip ofthe '156 application is incorporated herein by reference, and need notbe repeated further here, the test strip 98 is designed to separate thecolored (primarily hemoglobin) components of the blood from the clear,primarily plain components of the blood, to provide a generally clearanalyte fluid, that can then be reacted with reagents contained on thetest strip to form either a colorimetric or non-colorimetric reactionproduct that can then be analyzed either visually, or through the use ofa meter (not shown).

[0083] The test strip 98 includes a collection component that comprisesan inlet, a collection capillary structure to draw the fluid of interestinto the collection component via the inlet exerting capillary forcesupon the fluid applied to the inlet. The device also includes a filmthat is operable to collect the correct analyte from the fluid as thefluid is drawn over the film. A wicking component is provided that iscoupled to the collection component, and is structured to draw the fluidover the film and into the wicking component. The wicking componentexerts sufficient capillary force on the analyte fluid to effectivelysweep the film free of particulate matter (e.g. hemoglobin) of thefluid, without filtration or other mechanical removal devices. Thefunctional components described above of the test strip are incorporatedinto test strip 98.

[0084] The shape of test strip 98 is dictated largely by its need toincorporate the above-discussed functional components, while fittinginto the test strip holder 100 and test strip retainer 102, while stillbeing insertable into an appropriate glucose meter so that the glucosemeter can “read” the reaction product analyte that is drawn from thebody fluid (e.g. blood) that is placed on the collection component ofthe test strip 98. The test strip 98 includes a proximal end 108 and afluid sample receiving distal end 110. Generally, blood placed on a teststrip flows from the distal end 110 toward the proximal end 108.

[0085] Test strip 98 includes finger receiving apertures 112 that aredesigned for receiving an upstanding finger 130, whose purpose is tofixedly position the test strip 98 on the test strip holder 100 andreceiver 102. A pair of radially extending tabs 114 are formed on thetest strip 98 to also help to fixedly position the test strip 98 on thetest strip holder 100 and receiver 102.

[0086] The test strip 98 includes a body fluid receiving upper surface116 having a separating portion and a capillary containing portion, awicking component portion, and a reagent impregnated portion, as taughtby the above Kloepfer, Kloepfer and Roach patents. Generally, only oneside of the test strip 108 needs to be treated with the functionalcomponents, as blood is generally only placed one side 116 of the teststrip 98.

[0087] The test strip holder 100 includes a generally planar base forreceiving test strip 98 and a set of upstanding perimetral side walls124 for capturing the test strip 98, and maintaining it on the holder100 in a snug relationship. The test strip holder 100 also includes aconcave distal surface 128 that facilitates the introduction of blood tothe test strip 98, and a strip retaining upstanding finger 130, that maybe movable between a strip 98 engaging position and strip 98 releasingposition. A pair of ramping surfaces 142 are formed on the frontaldistal surface of the upstanding side walls 126 to facilitate thelifting of the test strip 98 by an appropriately designed glucose meter(not shown).

[0088] The test strip retainer 102 is designed to matingly engage withthe test strip holder 100, for retaining the test strip 98 by securingthe test strip 98 on the test strip component 94 of the blood testingdevice 10. The test strip retainer 102 is movable between an openposition, such as shown in FIGS. 1-4, and that permits the test strip 98to be inserted onto and/or removed from its engagement with the teststrip holder 100; and a closed position (see, e.g. FIG. 8) wherein thetest strip retainer 102 frictionally engages the test strip holder 100,so that the test strip retainer 102 is positionaly secured onto the teststrip holder 100, to positionaly secure and retain the test strip 98onto the test strip component 94. When so engaged, the test strip 98 issandwiched between the planar base 124 of the test strip holder 100, andtest strip retainer 102.

[0089] The test strip retainer 102 includes upstanding walls 136 forengaging the upper surface 116 of the test strip 98. The test stripretainer 102 is hingedly coupled to the test strip holder 100 by aliving hinge 104, and includes a generally perimetral strip engagingretaining wall set 138 that is designed to be disposed above the uppersurface 116 of the test strip 98.

[0090] The distal portion of the test strip retainer 102 includes aconcave cut-out portion for facilitating the introduction of blood ontothe test strip of the upper surface 116 of the test strip 98. A pair ofcomplimentary ramping surfaces 139 are formed on the distal end of theretainer 102, and are provided for facilitating engagement of thetesting strip component 94 with an appropriate glucose meter. Theprimary purpose of the ramping strip surfaces 132, 139 is to permit amechanism (not shown) within the glucose meter to lift the strip 98 asit is inserted into the meter for better fitting of the strip by themeter.

[0091] Another feature of the strip is the sufficient sample indicationwindow 141. This allows the meter to interrogate the strip in thereservoir to insure sufficient sample has been applied prior to giving atest result.

[0092] As is best shown in FIG. 3, the retainer 102 includes fourupstanding studs 137 that are sized and positioned for being receivedinto four complimentary apertures 140 that are formed on the test stripholder 100. When the studs 137 are inserted into the apertures 140, thestuds 137 fixedly engage the apertures 140 to maintain the retainer 102in a secure frictional engagement with the holder 100.

[0093] Your attention is now directed to FIG. 7b, that comprises a flowchart describing the manner in which the test strip device 10 is used.

[0094] First, the test strip device 10 is removed from its packaging.When packaged, the cap 54 is placed in its co-axial relationship withthe second end 14 of the testing device 10, so as to create a sealagainst the cleansing member 36, that helps to prevent the cleansingmember 36 from drying out.

[0095] When the device 10 is removed from its packaging, the cap 54 isopened, and moved from its co-axial position (see, e.g. FIG. 14) to itsparallel axis position, as shown in FIGS. 1-4. The user then employs thecleansing pad 36 to wipe the cleansing pad on an area of body tissuethat the user desires to have penetrated by the lancet 50 in order toremove a blood sample. After the area around the testing site is wipedwith the cleansing pad 36, the testing site is lanced with the useractuating trigger mechanism 94, to permit the spring 82 to move thelancet 50 axially, so that the penetrating tip 81 of the lancet 50penetrates the skin, to thereby allow blood to flow from the puncturesite. The depth to which the lancet 50 will insert itself into the skinis governed by the setting established by the user through the use ofthe depth gauge 86.

[0096] After the site is lanced, cap 54 is then moved back into itsco-axial position, primarily to help reduce the likelihood that the userwill re-stick himself with the lancet 50. As described above, the lancet50 can be designed with a two-way biasing mechanism so that the lancet50, after it is moved axially to engage the skin, will fall into theinfluence of a counter-spring to withdraw the lancet back below theaxially outwardly facing surface 38 of the cleansing member 36, toreduce the likelihood of such unintentional “sticks”.

[0097] From a functional perspective, an important reason to close theswab cap 54 is that it enables the user to employ the pressure cup 64 toenhance the flow of blood from the penetrated test site. Although it islikely that the pressure cup 64 would not be needed in allcircumstances, such as those circumstances where the site that is lancedis a fingertip, the pressure cup 64 is especially useful when the lancedsite is a relatively slower bleeding site such as a forearm.

[0098] The circumferential lid 66 of the pressure cup 64 is then placedaround the lanced site, and axially directed pressure is exerted againstthe body tissue. This causes additional quantities of blood to flow outof the lanced site. This finding was most surprising to Applicants, asenhanced blood flow was achieved by the Applicants, without the need toresort to vacuum assisted removal as in some prior art.

[0099] When sufficient blood has been bled out of the user, the bloodsample is then loaded on to the distal end 110 of the test strip 98.After a short interval necessary for the blood on the test strip tocomplete its journey through the capillary and wicking components of thetest strip 98, the distal end of the test strip component 94 is insertedinto an appropriately sized and configured glucose meter. Typically, itrequires the glucose meter approximately 5 to 10 seconds in order toperform its necessary analysis of the analyte fluid contained on uppersurface 116 of the test strip 98. After the glucose meter has performedits test, the user can then observe the results of the test or thedisplay of the glucose meter, which is typically either a liquid crystaldisplay, or light emitting diode display. After the results areobserved, the testing device 10 is removed from the glucose meter, anddisposed of appropriately. A visual back-up system can be used prior todisposing of the strip if the user has any doubts about the accuracy ofthe result (i.e. user feels bad but the result is in the acceptablerange).

[0100] It is believed by the Applicants that the entire testingprocedure utilizing the strip of the present invention should requireonly about 25 seconds of the user's time. The reader is invited tocompare the number of steps using the test device of the presentinvention with the significantly greater number of steps required forconventional testing, which is set forth in FIG. 7a. It is believed bythe Applicants that the consolidation of the various components upon asingle testing device 10 that is accomplished with the present inventionsaves the user considerable amounts of time, due largely tosignificantly fewer number of steps required to perform testing, and thesignificantly fewer number of components that must be manipulated by theuser. By comparison, the Applicants believe that a person using theprior art testing devices will require somewhere between 2 and 3 minutesto completely perform the task, which compares rather unfavorably to theestimated 25 seconds required by the device of the present invention.

[0101] The first alternate embodiment of the testing device 210 of thepresent invention is generally similar to testing device 10 in themanner it functions, but slightly different in its construction, and isshown in FIGS. 5-14 as including a body 212 that includes a first endbody portion 214 that is attachable to and joinable with a second endbody portion 216 via a central portion 217 to form the assembled testingdevice 210, as shown in FIGS. 8-14. The testing device 210 is alsogenerally pen-shaped, and includes a longitudinally extending axis A.The first end body portion 214 includes a radially outwardly facingcylindrical surface 220 having a knurled or otherwise roughened grippingsurface 222 for enhancing the user's ability to grip and control thedevice 210. The first end body portion 214 also includes a proximal end224 and a distal end 226. A reduced diameter portion 228 is disposedadjacent the distal end 226. The reduced diameter portion 228 is sizedfor interiorly receiving the proximal end of the central body portion217 within the generally hollow interior passageway of the distal end.The generally hollow interior passageway is defined by a generallycylindrical interior surface 232.

[0102] A bundt cake-shaped cleansing member receiver 223 (FIG. 13)having a hollow central finger 225 is disposed within the interior ofthe proximal end 224 of the first end body portion 214, and is sized andconfigured for receiving a toroidal-shaped absorbent cleansing member236, that is identical to cleansing pad 36. As will be described in moredetail below, the central aperture and hollow finger of the cleansingmember receiver are sized and positioned to permit lancet 250 (FIG. 6)to pass therethrough, so that when lancet 250 is in its fully extendedposition, the penetrating tip 281 of the lancet 250 will extend axiallyoutwardly beyond the axially extending outwardly facing surface of thecleansing member. Of course, when the lancet 250 is in its retractedposition, the penetrating tip is disposed axially inwardly of theaxially outwardly facing surface of the cleansing member 236, so that aperson using the cleansing member 236 to disinfect and clean a bodytissue area prior to penetration does not stick himself with the lancet250 while wiping down the tissue area.

[0103] Cap member 254 is identical to cap 54 and hingedly coupled to thesecond end body portion 214 by a snap-type living hinge member. The capmember 254 is movable between an open position (as shown in the figures,)wherein the longitudinal axis of the cap member 254 is generallyparallel to the longitudinal axis A of the testing device, in a closedposition as shown in FIGS. 8-14.

[0104] The distal end of the cap 254 is designed to mate with theproximal end of the first body portion 214, when the snap-type livinghinge moves the cap member 254 to its closed position.

[0105] The living hinge members 256 are “snap-type” living hinge membersthat are designed to be spring-tensioned so that the cap 254 only findsa rest position when the cap 254 is in its open position as shown inFIG. 5, or in its closed position wherein the cap is disposed co-axiallywith the second body portion 214, as shown in FIGS. 8-14.

[0106] The proximal end of the cap member includes a pressure cup 264that is defined by a circumferential pressure inducing lip, and acup-shaped interior. As with device 10, the placement of thecircumferential pressure extending lip on a tissue area that surrounds atissue site that has been penetrated by the tissue penetrator, alongwith the application of the moderate amount of axially directed force,has been surprisingly found by the Applicants to induce a flow of bloodout of the penetrated site to enhance the volume of blood that isobtained from the penetrated site.

[0107] An axially movable tissue penetrator 272, that is movable betweenthe retracted position, and an extended position includes a needle-liketissue penetrating lancet 250, that is fixedly coupled to an axiallymovable mounting carriage 278. It will be noted that the mountingcarriage 278 and the lancet 250 are coupled to the first end of aportion 216, but is separated from the central portion 217 unliketesting device 10. Nonetheless, when the device 210 is assembled, asshown in FIGS. 8-14, the carriage 278 and lancet 250 are interiorlyreceived within the hollow interior of the first end portion 214, sothat the penetrating tip 281 of the lancet 250 is disposed adjacent tothe proximal end 224 of the first end body portion 214. The lancet 250is movable between a retracted position wherein the penetrating tip 281is disposed axially inwardly of the axially outer facing surface of thecleansing member 236, so that when the user uses the cleansing member236 to cleans his finger, he does not stick himself with the tip 281 ofthe lancet 250. The lancet 250 is also movable into an extendedposition, wherein it is moved axially outwardly, under the force of abiasing member, such as spring 282 so that the penetrating tip 281extends axially outwardly beyond the axially outer facing surface of thecleansing member 236, to prick tissue site to cause bleeding therefrom.

[0108] One end 276 of the lancet 250 is coupled to a mounting collar onthe carriage 278, that couples the lancet 250 to the carriage 278.

[0109] Lancet 250 can be fixedly coupled to the movable carriage 278,and the carriage 278 can be designed to move axially, to cause the axialmovement of the lancet 250. Alternatively, the carriage 278 can befixedly positioned, and the lancet 250 be designed to be axiallymoveable relative to the carriage 278.

[0110] Spring 282 is provided for biasing the lancet 250 to move in anaxially outward direction, to engage tissue. A trigger member 284 isprovided for maintaining the lancet 250 in its retracted position, untilthe user actuates the trigger 284, that releases the spring 282 topermit the lancet 250 to move axially outwardly, to thereby prick atissue surface.

[0111] A depth gauge 286, including a camming surface for facilitatingaxial movement (not shown) is provided as a part of central portion 215for enabling the user to adjust the extent of axial movement of thelancet 250, that permits the user to adjust the depth to which thepenetrating tip 281 of the lancet 250 penetrates the tissue surface ofthe user. The depth gauge 286 includes pointer 288 (FIG. 9) that isreconcilable with numerical indicators 89 (FIG. 4) that provides anindication to the user of the relative depth to which the lancet 250will penetrate. A gripping surface 292 is provided for permitting theuser to rotate the cylindrical gauging wheel.

[0112] The second end body portion 216 also includes the test stripcomponent 294 that is disposed generally at the distal end 296 of thesecond end body portion. The test strip component 294, test strip 298,receiver 300 and retainer 302 are virtually identical to test stripcomponent 94, and does not need to be described again herein.

[0113] Testing device 210 also operates virtually identically to testingdevice 10, thereby eliminating the need to re-describe its method ofoperation.

[0114] The second alternate embodiment of the testing device 410 of thepresent invention is generally similar to testing device 10 insofar asit performs all of the functions of testing device 10. As is shown inFIGS. 15-20, device 210 utilizes a body 412 that includes a base member213 having a longitudinally extending first end body portion 414 that isattachable to and joinable with a lancet, cleansing member, and suctioncap containing second end body portion 416 via a generally disk-shapedcentral portion 417. The testing device 410 includes a first, test stripcomponent axis B, and a second lancet axis C, that is disposed at anouter angle to the test strip component axis B. The first end bodyportion 414 includes a radially outwardly facing ovaloid surface 420, aproximal end 424 and a distal end 426. A pair of Support braces 425 helpto securely connect the first end body portion 424 to the centralportion 417.

[0115] An ovaloid-shaped cleansing member receiver 423 (FIG. 17) havinga hollow central finger 429 is disposed within the interior of theproximal end 424 of the first end body portion 414, and is sized andconfigured for receiving a toroidal-shaped absorbent cleansing member36. As will be described in more detail below, the central aperture andhollow finger of the cleansing member receiver are sized and positionedto permit lancet 450 (FIG. 18) to pass therethrough, so that when lancet450 is in its fully extended position, the penetrating tip 481 of thelancet 450 will extend axially outwardly beyond the axially extendingoutwardly facing surface of the cleansing member. Of course, when thelancet 450 is in its retracted position, the penetrating tip 481 isdisposed axially inwardly of the axially outwardly facing surface of thecleansing member, so that a person using the cleansing member todisinfect and clean a body tissue area prior to penetration does notstick himself with the lancet 450 while wiping down the tissue area.

[0116] Cap member 454 is ovaloid in cross section, and is hingedlycoupled to the second end body portion 414 by a snap-type living hingemember 456. The cap member 454 is movable between an open position (asshown in FIGS. 15-17 and 20) wherein the longitudinal axis of the capmember 454 is generally parallel to the longitudinal axis C of thelancet 450, and a closed position wherein the cap member 454 is disposedgenerally co-axially with the lancet 450.

[0117] The distal end of the cap 454 is designed to mate with theproximal end of the first body portion 414, when the snap-type livinghinge moves the cap member 454 to its closed position.

[0118] The living hinge members 456 are “snap-type” living hinge membersthat are designed to be spring-tensioned so that the cap 454 only findsa rest position when the cap 454 is in its open position as shown inFIG. 5, or in its closed position wherein the cap is disposed co-axiallywith the second body portion 414.

[0119] The proximal end of the cap member 454 includes a pressure cup464 that is defined by a circumferential pressure inducing lip 466, anda cup-shaped interior. As with device 10, the placement of thecircumferential pressure extending lip on a tissue area that surrounds atissue site that has been penetrated by the tissue penetrator 481, alongwith the application of the moderate amount of axially directed force,has been surprisingly found by the Applicants to induce a flow of bloodout of the penetrated site to enhance the volume of blood that isobtained from the penetrated site.

[0120] An axially movable tissue penetrator 472 (FIG. 19), that ismovable between the retracted position, and an extended positionincludes a needle-like tissue penetrating lancet 450, that is coupled toa mounting member 478 The lancet 450 is movable between a retractedposition wherein the penetrating tip 481 is disposed axially inwardly ofthe axially outer facing surface of the cleansing member so that whenthe user uses the cleansing member to cleans his finger (or forearm orother sticking site), he does not stick himself with the tip 481 of thelancet 450. The lancet 450 is also movable into an extended position,wherein it is moved axially outwardly, under the force of a biasingmember, so that the penetrating tip 481 extends axially outwardly beyondthe axially outer facing surface of the cleansing member, to prick thetissue site to cause bleeding therefrom.

[0121] A depth gauge 486, including a camming surface for facilitatingaxial movement (not shown) is provided as a part of central portion 415for enabling the user to adjust the extent of axial movement of thelancet 450, that permits the user to adjust the depth to which thepenetrating tip 481 of the lancet 450 penetrates the tissue surface ofthe user. The depth gauge 486 includes pointer 488 (FIG. 15) that isreconcilable with numerical indicators 489 that provides an indicationto the user of the relative depth to which the lancet 450 willpenetrate. A gripping edge 492 is provided for permitting the user torotate the disk-shaped gauging wheel 479.

[0122] The second end body portion 416 also includes the test stripcomponent 494 that is disposed generally at the distal end 496 of thesecond end body portion. The test strip component 494, test strip 498,receiver 500 and retainer 502 are virtually identical to test stripcomponent 94, and do not need to be described again herein. Testingdevice 410 also operates virtually identically to testing device 10,thereby eliminating the need to re-describe its method of operation.

[0123] Although the invention has been described with reference to thecurrently perceived best mode of practicing the invention, it will beappreciated by those skilled in the art the variation and modificationsexist which are encompassed within the spirit of the invention.

What is claimed is:
 1. A body fluid testing device comprising: a bodymember a tissue penetrator carried by the body member a test stripholder carried by the body member, and a test strip carried by the teststrip holder, the test strip being capable of receiving a body fluidthereon and processing the body fluid into a form suitable for yieldingtest results relating to the content of the body fluid.
 2. The testingdevice of claim 1, further comprising a cleansing member carried by thebody member for cleansing a tissue area to be penetrated by the tissuepenetrator.
 3. The testing device of claim 1 further comprising apressure inducing member carried by the body member, the pressureinducing member being capable of inducing pressure on a tissue sitepenetrated by the penetrating member for inducing an enhanced flow offluid from the penetrated body tissue site.
 4. The testing device ofclaim 3 wherein the body member includes a hand engaging portion havinga gripping surface.
 5. The testing device of claim 3 wherein the bodymember includes a first end, a second end, and a hand engaging surfacedisposed between the first and second ends.
 6. The testing device ofclaim 5 wherein the tissue penetrator is axially movable between aretracted and an extended position, and includes a biasing member forbiasing the tissue penetrator into the extended position.
 7. The testingdevice of claim 6 wherein tissue penetrator includes an actuator forretaining the tissue penetrator in the retracted position, and uponactivation by the user, for releasing the tissue penetrator to permit itto move into the extended position.
 8. The testing device of claim 6,further comprising a cleansing member carried by the body member forcleansing a body tissue area to be penetrated by the tissue penetrator.9. The testing device of claim 8 wherein the cleansing member includesan aperture, and the penetrator is disposed adjacent the first end ofthe body portion and is extendable through the aperture in the cleansingmember as it moves from its retracted position to its axially extendedposition.
 10. The testing device of claim 9 wherein the tissuepenetrator includes a penetrating tip, the penetrating tip beingdisposed axially inwardly of an axially outer surface of the cleansingmember when the tissue penetrator is in the retracted position toprevent engagement of the penetrating tip with body tissue when thecleansing member is cleansing the tissue.
 11. The testing device ofclaim 9 wherein the tissue penetrator includes a depth adjuster forpermitting the user to adjust the axial distance traveled by the tissuepenetrator between its retracted and extended positions.
 12. The testingdevice of claim 8 wherein the cleansing member is disposed adjacent tothe first end of the body member, and includes a cleaner containing padfor cleaning the tissue area to be penetrated by the tissue penetrator.13. The testing device of claim 8 wherein the pressure inducing membercomprises a cap member disposed adjacent the first end of the bodymember, the cap member being hingedly coupled to the body member. 14.The testing device of claim 13 wherein the cap member is movable betweena closed position wherein the cleansing member is covered by the capmember, and an opened position.
 15. The testing device of claim 14wherein the cap member includes a cap portion disposed generallyco-axially with the body member when the cap member is in the closedposition, the cap portion including a tissue engaging rim defining anaxially inwardly extending cavity.
 16. The testing device of claim 9wherein the body fluid to be tested comprises mammalian blood.
 17. Thetesting device of claim 2 wherein the body member includes a first endand a second end, the first end includes a cleansing member receiver forreceiving the cleansing member.
 18. The testing device of claim 17wherein the cleansing member is generally toroidal and defines anaxially extending aperture through which the tissue penetrator can pass.19. The testing device of claim 18 wherein the tissue penetrator isdisposed adjacent to the first end of the body member, and is axiallymovable between an extended position wherein a portion of the tissuepenetrator extends through the axially extending aperture of thecleansing member receiver, and a retracted position.
 20. The testingdevice of claim 19 where the tissue penetrator includes a penetratingtip, the penetrating tip being disposed axially inwardly of an axiallyouter surface of the cleansing member when the tissue penetrator is inthe retracted position to prevent engagement of the penetrating tip withtissue when the cleansing member is cleansing tissue.
 21. The testingdevice of claim 20 wherein the test strip holder is disposed adjacent tothe second end of the body member, and wherein the test strip holderincludes a test strip receiver for receiving the test strip, and a teststrip retainer for retaining the test strip on the test strip receiver.22. The testing device of claim 20 further comprising a cap memberhingedly coupled to the first end of the body member, the cap memberbeing movable between a closed position for enclosing the cleansingmember and open position for exposing the cleansing member.
 23. Thetesting device of claim 22 wherein the cap member includes a livinghinge for hingedly coupling the cap member to the first end of the bodymember.
 24. The testing device of claim 1 wherein the tissue penetratoris axially movable between a retracted and an extended position, andincludes a biasing member for biasing the tissue penetrator into theextended position, the tissue penetrator further including an actuatorfor retaining the tissue penetrator in the retracted position, andreleasing the tissue penetrator upon activation by the user, to moveinto the extended position.
 25. The testing device of claim 24, furthercomprising a cleansing member carried by the body member and having anaxially outer cleansing surface for cleansing a body tissue area to bepenetrated by the tissue penetrator, wherein the tissue penetratorincludes a penetrating tip, the penetrating tip being disposed axiallyinwardly of the axially outer cleansing surface of the cleansing memberwhen the tissue penetrator is in the retracted position to preventengagement of the penetrating tip with body tissue when the cleansingsurface is engaging the tissue.
 27. The testing device of claim 26wherein the cleansing member includes an aperture, and the penetrator isdisposed adjacent the first end of the body portion and is extendablethrough the aperture in the cleansing member as it moves from itsretracted position to its axially extended position, and the tissuepenetrator includes a depth adjuster for permitting the user to adjustthe axial distance traveled by the tissue penetrator between itsretracted and extended positions.
 28. The testing device of claim 1wherein the test strip holder includes a test strip receiver forreceiving the test strip, and a test strip retainer for retaining thetest strip on the test strip receiver.
 29. The testing device of claim28 wherein the test strip holder includes a hinge for hingedly couplingthe test strip receiver to the test strip retainer.
 30. The testingdevice of claim 28 wherein at least one of the test strip receiver andtest strip retainer arc positioned in a spaced relation from the teststrip for facilitating engagement of the test strip with a testingmeter, to permit the testing meter to impart a lifting movement to thetest strip.
 31. The testing device of claim 1 wherein the test stripholder includes a window for permitting the user to view the test stripto determine whether sufficient body fluid has been applied to the teststrip to give a precise and accurate result.
 32. The testing device ofclaim 1 wherein the test strip includes a reaction area and a reagentcapable of producing a color upon reaction with the body fluid, wherebythe color provides an indication of the test results.